Clinical outcomes in percutaneous coronary interventions with polymer-free vs. durable-polymer stents: a metanalysis of randomized clinical trials

Background Polymer-free (PF) stents were designed as an alternative to durable-polymer (DP) drug-eluting stents to minimize the time on dual antiplatelet treatment for patients at high-risk of bleeding. Nonetheless, the efficacy and safety of PF vs. DP stents in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Methods We performed a metanalysis with currently available studies that assessed the effect of PF-stents vs. DP-stents after performing a systematic search. The endpoints analyzed were all-cause death, myocardial infarction, target lesion revascularization (TLR) and probable or definite stent thrombosis. The raw numbers of incident end-points reported in each study were used. We performed analyses in short and long term (<1 or >1 year follow-up) studies. Results We included 12464 patients from 8 studies (5 short-term and 3 long-term): 6723 treated with PF-stents and 5741 with DP stents. Females represented 23.3% (n=3284) and 33.7% (n=4202) were included in the setting of acute coronary syndromes. As shown in the figure, PF-stents were associated to lower incidence of all-cause mortality (HR: 0.91 95% CI 0.84–0.98; p=0.016) and TLR (HR: 0.88 95% CI 0.80–0.96; p=0.003). No differences were observed in the risk of cardiovascular death (HR: 0.96 95% CI 0.86–1.06 p=0.415), myocardial infarction (HR: 0.90 95% CI 0.80–1.01; p=0.061) or probable-definite stent thrombosis (HR: 0.92 95% CI 0.74–1.14; p=0.447). Finally, no differences in the primary end-point (HR: 0.92 95% CI 0.83–1.03; p=0.143) were detected with PF-stents vs. DP-stents. No significant heterogenicity was observed in any of the endpoints, except for the incidence of stent thrombosis. Conclusions Under current PCI techniques the use of PF-stent might be associated to better outcomes, especially in terms of all-cause mortality and TLR. FUNDunding Acknowledgement Type of funding sources: None.

Cangrelor Use in Routine Practice: A Two-Center Experience

Cangrelor is the first and only intravenous P2Y12-inhibitor and is indicated when (timely) administration of an oral P2Y12 inhibitor is not feasible in patients undergoing percutaneous coronary intervention (PCI). Our study evaluated the first years of cangrelor use in two Dutch tertiary care centers. Cangrelor-treated patients were identified using a data-mining algorithm. The cumulative incidences of all-cause death, myocardial infarction, definite stent thrombosis and major bleeding at 48 h and 30 days were assessed using Kaplan–Meier estimates. Predictors of 30-day mortality were identified using uni- and multivariable Cox regression models. Between March 2015 and April 2021, 146 patients (median age 63.7 years, 75.3% men) were treated with cangrelor. Cangrelor was primarily used in ST-segment elevation myocardial infarction (STEMI) patients (84.2%). Approximately half required cardiopulmonary resuscitation (54.8%) or mechanical ventilation (48.6%). The cumulative incidence of all-cause death was 11.0% and 25.3% at 48 h and 30 days, respectively. Two cases (1.7%) of definite stent thrombosis, both resulting in myocardial infarction, occurred within 30 days, but after 48 h. No other cases of recurrent myocardial infarction transpired within 30 days. Major bleeding occurred in 5.6% and 12.5% of patients within 48 h and 30 days, respectively. Cardiac arrest at presentation was an independent predictor of 30-day mortality (adjusted hazard ratio 5.20, 95%-CI: 2.10–12.9, p < 0.01). Conclusively, cangrelor was used almost exclusively in STEMI patients undergoing PCI. Even though cangrelor was used in high-risk patients, its use was associated with a low rate of stent thrombosis.

Ticagrelor Versus Clopidogrel in ST Segment Elevation Myocardial Infarction Patients Candidate for Primary Percutaneous Coronary Intervention

Objective: To evaluate the incidence rate of definite stent thrombosis and major adverse cardiovascular events (MACE) with Ticagrelor versus Clopidogrel in ST segment elevation myocardial infarction (STEMI) patients candidate for primary percutaneous coronary intervention (PCI). Methods: STEMI participants naïve to antiplatelets, with no history of coronary artery disease (CAD) and candidate for primary PCI were included, while participants with history of CAD were excluded. Two hundred consecutive participants were selected, divided into 2 groups of 100 participants each, received either Ticagrelor or Clopidogrel, and followed up at 3 and 6 months. Results: The percent of patients in the Ticagrelor group who developed definite stent thrombosis (in-hospital and total) was 0%, while the percent of patients in the Clopidogrel group who developed definite stent thrombosis (in-hospital and total) was 8% and 9%, respectively. There were statistically significant weak associations between the class of P2Y12 platelet inhibitors and definite stent thrombosis (in-hospital and total) (X2 = 8.33, P = .004, V = 0.204 and Χ2 = 9.424, P = .002, V = 0.217, respectively). The percent of patients in the Ticagrelor and Clopidogrel groups who developed in-hospital MACE was 1% and 9%, respectively. There was a statistically weak significant association between the class of P2Y12 platelet inhibitors and in-hospital MACE (X2 = 6.74, P = .009, V = 0.184). Conclusion: Ticagrelor is more efficacious than Clopidogrel in preventing definite stent thrombosis (in-hospital and total) and in-hospital MACE in STEMI patients.

Changes in demographics, clinical practices and long-term outcomes of patients with ST segment-elevation myocardial infarction who underwent coronary revascularisation in the past two decades: cohort study

ObjectiveTo evaluate changes in demographics, clinical practices and long-term clinical outcomes of patients with ST segment-elevation myocardial infarction (STEMI) before and beyond 2010.DesignMulticentre retrospective cohort study.SettingThe Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) AMI Registries Wave-1 (2005–2007, 26 centres) and Wave-2 (2011–2013, 22 centres).Participants9001 patients with STEMI who underwent coronary revascularisation (Wave-1: 4278 patients, Wave-2: 4723 patients).Primary and secondary outcome measuresThe primary outcome was all-cause death at 3 years. The secondary outcomes were cardiovascular death, cardiac death, sudden cardiac death, non-cardiovascular death, non-cardiac death, myocardial infarction, definite stent thrombosis, stroke, hospitalisation for heart failure, major bleeding, target vessel revascularisation, ischaemia-driven target vessel revascularisation, any coronary revascularisation and any ischaemia-driven coronary revascularisation.ResultsPatients in Wave-2 were older, more often had comorbidities and more often presented with cardiogenic shock than those in Wave-1. Patients in Wave-2 had shorter onset-to-balloon time and door-to-balloon time, were more frequently implanted drug-eluting stents, and received guideline-directed medication than those in Wave-1. The cumulative 3-year incidence of all-cause death was not significantly different between Wave-1 and Wave-2 (15.5% and 15.7%, p=0.77). The adjusted risk of all-cause death in Wave-2 relative to Wave-1 was not significant at 3 years (HR 0.92, 95% CI 0.83 to 1.03, p=0.14), but lower beyond 30 days (HR 0.86, 95% CI 0.75 to 0.98, p=0.03). The adjusted risks of Wave-2 relative to Wave-1 were significantly lower for definite stent thrombosis (HR 0.59, 95% CI 0.43 to 0.81, p=0.001) and for any coronary revascularisation (HR 0.75, 95% CI 0.69 to 0.81, p<0.001), but higher for major bleeding (HR 1.34, 95% CI 1.20 to 1.51, p=0.005).ConclusionsWe could not demonstrate improvement in 3-year mortality risk from Wave-1 to Wave-2, but we found reduction in mortality risk beyond 30 days. We also found risk reduction for definite stent thrombosis and any coronary revascularisation, but an increase in the risk of major bleeding from Wave-1 to Wave-2.

Demographics, practice patterns and long-term outcomes of patients with non–ST-segment elevation acute coronary syndrome in the past two decades: the CREDO-Kyoto Cohort-2 and Cohort-3

ObjectivesTo evaluate patient characteristics and long-term outcomes in patients with non–ST-segment elevation acute coronary syndrome (NSTEACS) in the past two decades.DesignMulticenter retrospective study.SettingThe Coronary REvascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) Registry Cohort-2 (2005–2007) and Cohort-3 (2011–2013).Participants3254 patients with NSTEACS who underwent first coronary revascularisation.Primary and secondary outcome measuresThe primary outcome was all-cause death. The secondary outcomes were cardiovascular death, cardiac death, sudden cardiac death, non-cardiovascular death, non-cardiac death, myocardial infarction, definite stent thrombosis, stroke, hospitalisation for heart failure, major bleeding, any coronary revascularisation and target vessel revascularisation.ResultsPatients in Cohort-3 were older and more often had heart failure at admission than those in Cohort-2. The prevalence of PCI, emergency procedure and guideline-directed medical therapy was higher in Cohort-3 than in Cohort-2. In patients who received PCI, the prevalence of transradial approach, drug-eluting stent use and intravascular ultrasound use was higher in Cohort-3 than in Cohort-2. There was no change in 3-year adjusted mortality risk from Cohort-2 to Cohort-3 (HR 1.00, 95% CI 0.83 to 1.22, p=0.97). Patients in Cohort-3 compared with those in Cohort-2 were associated with lower adjusted risks for stroke (HR 0.65, 95% CI 0.46 to 0.92, p=0.02) and any coronary revascularisation (HR 0.76, 95%CI 0.66 to 0.87, p<0.001), but with higher risk for major bleeding (HR 1.25, 95% CI 1.06 to 1.47, p=0.008). The unadjusted risk for definite stent thrombosis was lower in Cohort-3 than in Cohort 2 (HR 0.29, 95% CI 0.11 to 0.67, p=0.003).ConclusionsIn the past two decades, we did not find improvement for mortality in patients with NSTEACS. We observed a reduction in the risks for definite stent thrombosis, stroke and any coronary revascularisation, but an increase in the risk for major bleeding.

Impact of intraprocedural stent thrombosis on outcomes of percutaneous coronary intervention: a meta-analysis

Background Intraprocedural stent thrombosis (IPST), defined as the development of occlusive or nonocclusive new thrombus in or adjacent to a recently implanted stent before completion of PCI. IPST even though a rare entity, yet is associated with worse prognosis amongst all intraprocedural thrombotic events. Purpose Data regarding the impact of IPST is scarce and needs further investigation. Methods We performed literature search of all published full-length articles that studied and compared data on patients with IPST and with no IPST during PCI. We calculated odds ratios via the random effects model for 30 day and 1 year outcomes. Results Our literature search yielded 3 studies (1 retrospective, 2 observational post-hoc analysis) relevant to the meta-analysis. Total 19272 patients were included. IPST occurred in 159 patients (0.8%). At 30 days, IPST was associated with statistically significant higher all-cause mortality (OR 10.79, 95% CI [6.31, 18.45] p&lt;0.00001), MI (OR 4.82, 95% CI [2.39, 9.73] p&lt;0.0001), target vessel revascularization (TVR) (OR 6.70, 95% CI [3.38, 13.29] p&lt;0.00001), definite stent thrombosis (OR 10.44, 95% CI [5.87, 18.58] p&lt;0.00001), definite or probable stent thrombosis (OR 9.28), 95% CI [5.54, 15.56] p&lt;0.00001) and death or MI or TVR (OR 7.20], 95% CI [4.10, 12.64] p&lt;0.00001), than those without IPST. At one year, results remained statistically significant for higher mortality (OR 4.27, 95% CI [1.92, 9.49] p=0.0004) and death or MI or TVR (OR 2.91, 95% CI [1.58, 5.36] p=0.0006) in patients with IPST. Conclusions IPST even though is a rare occurrence, is associated with more adverse ischemic events, including higher mortality at 30 days and 1 year. Funding Acknowledgement Type of funding source: None

Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis

Aims This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. Methods Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1–12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. Results Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654–1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711–1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). Conclusion After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial

Aims To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS). Methods and results In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n = 388, VKA n = 389) vs. CCS (edoxaban n = 363, VKA = 366). Participants received edoxaban 60 mg once-daily plus a P2Y12 inhibitor for 12 months, or VKA combined with a P2Y12 inhibitor and aspirin 100 mg (for 1–12 months). The primary bleeding endpoint at 12 months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59–1.02, P = 0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68–1.31, P = 0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70–1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47–1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573). Conclusions In patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation.